Spinal Cord Injury Exercise and Nutrition Conceptual Engagement: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (NCT03495986), a randomized na study. The primary outcome is Percent Body Fat Assessed by DXA at Baseline and 21 Weeks.

2. Clinical Question

The registry describes a randomized comparison of two approaches: adding home-based functional electrical stimulation leg cycle ergometry to a diet intervention, or receiving the diet intervention alone. The primary outcome is percent body fat measured by dual-energy X-ray absorptiometry, abbreviated DXA, at baseline and 21 weeks. The intended question concerns body composition over time and whether the groups differed on that measure.

The registry also names secondary outcomes involving HDL-C, the total cholesterol-to-HDL-C ratio, hsCRP, and femur bone mineral density. It lists nine outcome measures in total. However, it records zero analysis entries, and the primary outcome is not reduced to a single comparison because it has multiple categories or time points. The group-level primary outcome values, an estimated between-group contrast, and its uncertainty are not reported in the registry record. Consequently, the direction, size, and precision of any difference in body fat cannot be described from the posted results.

3. Trial Design

This was a randomized, parallel-group trial sponsored by the University of Miami. The registry reports an enrollment of 26 and a completed status. It lists the study phase as NA. The record describes no masking. These design features establish that participants were allocated at random to one of two concurrent groups, but do not by themselves establish how allocation was generated or concealed; those details are not reported in the registry record.

One group was assigned a 16-week home-based functional electrical stimulation leg cycle ergometry exercise program together with a diet intervention. The comparator group was assigned a diet intervention alone. The registry identifies functional electrical stimulation leg cycle ergometry as a device intervention and diet as a behavioral intervention. Further details about the exercise regimen, diet content, adherence monitoring, or support provided are not reported in the registry record.

The study start date is 2021-06-10, and the primary completion date is 2024-07-24. The primary outcome is percent body fat assessed by DXA at baseline and 21 weeks. The record describes the measure as a mean with standard deviation and says that the assessments were intended to evaluate changes in body composition over time. No group means, standard deviations, changes, or between-group estimates for this endpoint are reported in the registry record.

The record lists nine outcome measures and zero analysis entries. It names four secondary outcomes: HDL-C, change in the total cholesterol-to-HDL-C ratio, hsCRP, and lower extremity bone mineral density at the femur. The registry does not provide enough analysis detail to determine which model, contrast, or population was used for any outcome. Random allocation can support a fair comparison when carried through the analysis, but the outcome results and analysis procedures needed to assess that comparison are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Percent body fat was analyzed using DXA.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Percent Body Fat Assessed by DXA at Baseline and 21 Weeks, measured over Baseline, 21 weeks.

The primary endpoint is percent body fat assessed by DXA at baseline and 21 weeks. DXA is an imaging-based method used to assess body composition; in this trial, the reported quantity is the percentage of body fat. The registry specifies that this is a continuous measure summarized using a mean and standard deviation. Its description says the two assessment occasions were intended to evaluate changes in body composition over time.

As a general statistical point, a continuous endpoint can be described using its group mean and the spread of individual measurements. A comparison can then express how the groups differ, or how their changes over time differ, depending on the prespecified analysis. Those are distinct estimands: a comparison at follow-up is not necessarily the same as a comparison of change from baseline. The precise primary contrast and model are not reported in the registry record, so it is not possible to identify which of these the trial intended to estimate.

Measuring body fat as a percentage gives a body-composition outcome rather than a direct measure of symptoms, function, or quality of life. That distinction matters when interpreting what an endpoint can establish. The registry’s endpoint description defines the measurement and assessment times, but does not report the observed values or an estimated effect. Therefore, the posted record does not show whether mean percent body fat changed, how much it changed, or how precisely the two groups differed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Randomized trials assign participants to groups by chance. General statistical rationale: random allocation can reduce systematic differences between groups at the start of a study, on average, and supports estimating the effect of assignment to the study strategies. It does not guarantee that every characteristic is balanced in a particular trial, nor does the word “randomized” reveal the method used to generate or conceal assignments. The registry identifies randomized allocation but does not report those procedural details.

What does a parallel-group design mean?

In a parallel-group design, participants are assigned to one group and followed under that group’s strategy rather than crossing between strategies. Here, the registry describes a home-based exercise program plus diet and a diet-alone group. The two groups therefore provide the intended concurrent comparison. The record does not report whether participants adhered to their assigned strategies or how adherence was assessed.

What does the primary endpoint measure?

The primary measure is percent body fat assessed by DXA at baseline and 21 weeks. The registry characterizes it as continuous and says it is summarized as a mean with standard deviation. A mean gives the arithmetic average of observed measurements in a group. A standard deviation describes how dispersed individual measurements are around that average. These summaries are not reported for the primary endpoint, so the posted record does not allow readers to assess the outcome distributions or reproduce a comparison.

Why does the choice of contrast matter?

General statistical explanation: a trial with measurements at baseline and follow-up can be analyzed in more than one way. One approach compares the groups at follow-up; another compares their changes from baseline; a model may also account for baseline values while estimating a follow-up contrast. These approaches answer related but not identical questions and rely on different modeling choices. The registry describes assessments at baseline and 21 weeks, but does not report the intended primary contrast or statistical model. The primary outcome is explicitly not reduced to one comparison because it has several categories or time points. It would therefore be inappropriate to infer a particular analysis from the measurement schedule alone.

How should uncertainty be understood?

General statistical explanation: an estimate is a numerical summary of a quantity of interest, such as a difference between group means. A confidence interval conveys sampling uncertainty around an estimate under the assumptions of the analysis. A narrower interval generally indicates greater precision, while an interval spanning a wide range of plausible effects indicates less precision. A p-value describes how compatible the observed data are with a specified null hypothesis under a statistical model; it does not indicate the probability that the null hypothesis is true, and it does not measure effect size. No primary estimate, confidence interval, or p-value is reported in the registry record, so these concepts cannot be applied to a numerical primary result.

What can the planning assumptions tell readers?

The registry gives assumptions for planning illustrations: a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. General statistical explanation: a planning calculation asks what sample size would be needed to detect a chosen effect under specified assumptions. It is not an observed finding, and it is not “observed power.” A calculation based on an observed effect is especially dependent on the effect estimate used and its uncertainty. The primary outcome does not have a single reported comparison, and its effect is not reported in the registry record, so there is no primary effect available to anchor such an illustration. The actual sample-size justification and the trial’s own design calculations are not reported in the registry record.

Why might over-dispersion matter?

General statistical explanation: over-dispersion occurs when the variability in data is greater than a statistical model expects. If a model assumes less variability than the data contain, standard errors can be too small and uncertainty can be understated. The relevance of over-dispersion depends on the data type and model. The primary endpoint is continuous, but the analysis model and any assessment of its assumptions are not reported in the registry record. It is therefore not possible to determine whether over-dispersion was relevant or how variability was handled.

What can be inferred from the registry’s analysis entries?

The record lists nine outcome measures and zero analysis entries. It also identifies the primary measure’s baseline and 21-week assessments, but supplies no group summaries or inferential results. The absence of analysis entries should be read as a limitation of the posted record, not as an analysis showing no difference. Details such as covariate adjustment, missing-data handling, treatment of repeated measurements, prespecified hypothesis testing, and analysis population are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists nine outcome measures, including the primary measure and secondary measures of HDL-C, change in the total cholesterol-to-HDL-C ratio, hsCRP, and femur bone mineral density. Considering several outcomes or time points can raise multiplicity concerns: the more statistical comparisons made, the greater the chance of at least one apparently notable result arising by chance if no adjustment or prespecified hierarchy is used. This is a general statistical concern, not a statement that a particular error occurred in this trial.

The registry record does not report a multiplicity adjustment, testing hierarchy, or complete analysis plan. It records zero analysis entries, and the primary outcome is not reduced to a single comparison because it includes multiple categories or time points. Therefore, the intended primary test and the relationship between primary and secondary testing are not reported in the registry record. No inferential results are available to assess.

Missing-data methods and analysis populations are also not reported in the registry record. The posted information does not say how many participants contributed primary outcome measurements at each assessment, how missing observations were handled, or whether analyses followed assignment regardless of adherence. Those details matter because analyses based on different participant sets or assumptions about missing outcomes can yield different estimates. Without them, the population represented by any outcome comparison cannot be established from the registry record.

General statistical explanation: a missing measurement is not automatically equivalent to an unchanged outcome, and excluding participants with missing data can introduce bias when missingness is related to participant characteristics or outcomes. Appropriate methods depend on why data are missing and on the analysis objective. The registry does not provide enough information to evaluate these issues for the primary or secondary outcomes.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: heart failure (7.7%), urinary tract infection (uti) (7.7%), heterotopic ossification (7.7%), pulmonary embolism (7.7%), hyponatremia (7.7%).

The registry reports serious and other adverse-event counts for each group, with 13 participants at risk in each group. In the Home-Based Exercise & Diet Group, 5 participants were reported with serious adverse events and 7 with other adverse events. In the Home-Based Diet Alone Group, 2 were reported with serious adverse events and 1 with other adverse events. The registry reports zero deaths in each group. These counts describe what the record lists; they do not establish that an intervention caused an event or that the groups differ in safety.

The serious-event terms listed are heart failure, urinary tract infection (UTI), heterotopic ossification, pulmonary embolism, hyponatremia, and autonomic dysreflexia. Each is accompanied by a reported rate of 7.7%. The registry record does not explain whether these rates refer to participants, events, or another denominator, nor whether one participant could contribute more than one term. The term-specific rates should therefore be read as listed, without inferring a count or recalculating a percentage.

General statistical explanation: adverse-event counts are descriptive unless accompanied by a suitable comparison and enough detail about event ascertainment, follow-up, and denominators. These details, as well as an inferential safety analysis, are not reported in the registry record. The counts alone do not show the seriousness of every event, its timing, or its relationship to assigned treatment.

12. What the Result Does, and Does Not, Mean

The registry record documents a completed randomized comparison of a home-based functional electrical stimulation exercise program plus diet against diet alone. It identifies percent body fat assessed by DXA at baseline and 21 weeks as the primary outcome. This establishes the study’s central measurement and comparison, but it does not provide the numerical outcome results needed to describe what happened to body fat in either group.

There is no reported primary outcome mean, change, group contrast, confidence interval, or p-value. As a result, the posted record does not indicate whether the groups differed, the direction of any difference, its magnitude, or how precisely it was estimated. The missing result cannot be interpreted as no effect, no change, or equivalent outcomes. Nor can the trial’s completed status substitute for a reported analysis.

The adverse-event counts are separate descriptive information. They report serious events, other events, and deaths by group, but do not establish causation or provide a formal comparative analysis. The registry’s serious-event term rates also lack enough explanation to clarify their counting basis. These figures should not be treated as a complete account of the benefits and risks of either strategy.

General statistical explanation: a trial result is best interpreted through its prespecified question, effect estimate, and uncertainty, alongside the design and limitations of the analysis. A numerical estimate can be compatible with a range of effects, and its precision affects how strongly it supports a conclusion. Since the primary estimate and its uncertainty are not reported in the registry record, no conclusion about the comparative body-composition result can be drawn from the posted data alone.

The record also does not report the analysis population, missing-data approach, adherence, or the statistical procedures used for the primary endpoint. These omissions limit assessment of how the randomized comparison was carried through to an estimate. The registry supports a description of the intended trial question and the recorded adverse-event counts, but not a claim about the primary outcome’s result.

13. Why This Trial Matters Statistically

This trial is statistically notable for the gap between a clearly identified randomized comparison and the lack of a reported primary outcome analysis. The registry specifies the two strategies, the primary measure, and assessment times. Yet it lists zero analysis entries, and the primary outcome has multiple categories or time points rather than a single reported comparison. Readers can identify the intended question but cannot evaluate the effect estimate or its precision.

That distinction is important in clinical research. Trial design describes how a comparison was intended to be made; results show what the data estimate. Randomization alone does not reveal the size or direction of an outcome difference. Likewise, a completed status does not communicate the primary finding. Without group summaries and an uncertainty measure, neither a positive nor a null interpretation of the primary comparison is supported by the registry record.

The record also illustrates why endpoints and analysis plans need to be read together. A continuous measure assessed at baseline and follow-up can support different contrasts, and multiple outcomes or time points make clarity about the primary comparison particularly important. The intended contrast, handling of missing observations, and approach to multiplicity are not reported in the registry record. Those details would help readers understand exactly which question the analysis was designed to answer and how robustly it was addressed.

Finally, the adverse-event counts are useful descriptive information, but they do not replace a transparent safety analysis. The group counts and term rates are reported without enough detail to assess comparative uncertainty or interpret all denominators. Overall, the registry record allows readers to characterize the trial design and identify important reporting gaps, while leaving the primary efficacy comparison unresolved.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

A central limitation of the posted record is that it does not report numerical results for the primary endpoint. No group means, standard deviations, changes, between-group estimate, confidence interval, or p-value are included. The record lists zero analysis entries and notes that the primary outcome has multiple categories or time points, so it is not reduced to a single comparison. This prevents assessment of effect direction, magnitude, and precision.

The analysis details needed to interpret a randomized comparison are also not reported in the registry record. These include the primary statistical model and contrast, analysis population, missing-data handling, covariate adjustment, adherence, and any multiplicity strategy. Without these details, it is not possible to judge how the recorded design was translated into an analysis or whether the reported outcome population corresponds to all randomized participants.

Descriptions of the interventions are limited. The record identifies a 16-week home-based functional electrical stimulation leg cycle ergometry program plus diet and a diet-alone comparator, but does not report the diet content, exercise dose beyond the program description, adherence, or implementation procedures. Such information would help characterize what participants actually received and how consistently the assigned strategies were delivered.

The adverse-event information is also limited. The record provides group counts and serious-event terms with rates, but does not clarify the term-specific denominators or event-counting rules. It does not provide a comparative safety analysis or enough detail to determine timing and attribution. These are limitations of what the registry record reports and should not be read as proof that the trial failed to collect the information.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Spinal Cord Injury Exercise and Nutrition Conceptual Engagement — NCT03495986.
• Registry record last updated 2025-12-22; status last verified 2025-12.
• Results first posted 2025-12-22.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The University of Miami-sponsored SCIENCE trial is listed as completed and randomized, with a parallel-group design and no masking. Enrollment was 26. The study start date was 2021-06-10, and the primary completion date was 2024-07-24. The registry lists the phase as NA.

The trial compared a 16-week home-based functional electrical stimulation leg cycle ergometry program plus diet with diet alone. Its primary outcome was percent body fat assessed by DXA at baseline and 21 weeks. The registry lists nine outcome measures and zero analysis entries; primary outcome results and a single comparison are not reported in the registry record.

Adverse-event counts are listed for 13 participants at risk in each group. Serious events were reported for 5 participants in the exercise-and-diet group and 2 in the diet-alone group; other events were reported for 7 and 1, respectively. No deaths were reported in either group. These counts are descriptive and do not provide a comparative analysis.